Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects.

BACKGROUND AND OBJECTIVE: The post-trial follow-up (PTFU) phase of a clinical trial can provide important information on maintenance of intervention effects. However, approaches for the PTFU are rarely described. This short communication describes our process for PTFU that involved recontacting older subjects who participated in a clinical trial between 2015 and 2019. We also describe correlates of response to our PTFU survey. METHODS: The parent clinical trial aimed to reduce depression symptoms among older spousally-bereaved adults. We attempted to recontact our sample during the early stages of the COVID-19 pandemic. Using logistic regression, we examined physical health, depression symptoms, cognitive status, and disability as correlates of participant response to the PTFU phase. RESULTS: Forty-two percent of participants responded to the PTFU survey. Disability - or the inability to participate in major life tasks and social roles - was significantly associated with response. Participants with greater disability were less likely to respond to the PTFU survey. CONCLUSIONS: Older adults with disabilities may need alternative and supportive strategies for engaging in the PTFU phase. CLINICAL TRIALS REGISTRATION: NCT02631291.

Profiles of Autistic Youth with and Without Co-occurring Behavioral Health and Neurodevelopmental Disorders: A Latent Class Analysis.

OBJECTIVE: Autism spectrum disorder (ASD) diagnosis relies on clinical observation and documentation, but the presence of comorbidities can affect diagnostic validity across clinicians and exacerbate access to timely care. This study used latent class analysis to optimize subgroup identification based on functional level and associated comorbidities using the Behavior Assessment System for Children, Third Edition (BASC-3), and Vineland Adaptive Behavior Scales, Third Edition (Vineland-3), in a pediatric population referred for autism evaluation. METHODS: This retrospective study reviewed clinical data extracted over a 3-year period (2018-2021). A latent class analysis was used to explore the presence of latent groups guided by the likelihood ratio test and fit indices. Additional analyses contrasted ASD and non-ASD groups on the BASC-3 and Vineland-3 variables. RESULTS: There were 191 included participants (mean age 65.9 months, 76.4% male), of whom over half (60.7%) had an ASD diagnosis. Using 185 cases, the exploratory latent class analysis showed the emergence of 4 distinct subgroups. Composition of classes varied on ASD diagnosis, neurodevelopmental difficulties, behavioral health concerns, and intellectual disability. When contrasting ASD and non-ASD groups, significant between-group differences were observed across Vineland-3 variables and BASC-3 adaptive skills subscales indicating poorer social and adaptive functioning. CONCLUSION: Latent class analysis of commonly used behavioral and adaptive measures can help distinguish between subgroups of pediatric patients referred for ASD evaluations and assist in triage of cases based on severity.

Animal use in detection of disease within pediatric populations.

There is a need for novel techniques for disease detection in humans. Research has shown that using animals for detection of disease is a promising area of study. A literature review was conducted using the terms animals, disease detection, seizures, epilepsy, infectious disease, cancer, and pediatrics to determine the published literature to date of the use of animals in detection of disease. Research studies between 1999-2022 were included in this article. The published studies demonstrate that animals have been used for disease detection in seizures, infectious diseases, Type I diabetes mellitus, and cancer. However, these studies have predominantly focused on the adult patient population. There is limited data available regarding the use of animals in disease detection within pediatrics, which warrants further research into this topic.

Incorporating technology in research with older bereaved adults: Lessons learned from conducting an internet-based randomized controlled trial.

Objective: Digital health interventions (DHI) involve multiple interactions between the user, technology platform, and study team, posing challenges for implementation. This paper describes the lessons learned while implementing an internet-based randomized controlled trial (RCT) for reducing depression symptom burden in older acutely-bereaved adults. Methods: The RCT was entitled "Widowed Elders' Lifestyle after Loss" (or WELL), which compared the efficacy of a DHI to an enhanced usual care (EUC) for reducing depression symptoms in adults 60+ years who lost their spouse/life partner within the previous 12 months. Participants randomized to the DHI used their own tablet, smartphone, or pc to record the timing and regularity of sleep, meals, and physical activity twice daily, for 12 weeks. The also received weekly health coaching sessions from a clinician certified in motivational interviewing. Participants randomized to the EUC arm received weekly calls from research staff and were assessed on the same schedule as intervention participants. All study procedures were conducted virtually. Methodological and procedural challenges were discussed weekly with study staff and the primary investigator. Results: Many challenges can be categorized as follows recruiting virtually, obtaining informed consent, training older adults to use technology, and establishing rapport with older adults. Solutions required researcher and interventionist flexibility in adapting to new strategies. For instance, we redesigned the informed consent process to include a user-friendly brochure that enhanced participants' understanding of the RCT and improved our enrollment rate. We also utilized user-engagement in refining an intervention protocol. Conclusion: We resolved implementation challenges without compromising internal validity via interdisciplinary collaborations with mobile programmers to ensure our technology met the unique and varied needs of aging users. The solutions from this study may promote the recruitment and retainment of older adults in research studies that use technology-based interventions.

Expansion of Pharmacy Services During COVID-19: Pharmacists and Pharmacy Extenders Filling the Gaps Through Telehealth Services.

Purpose: The Coronavirus 2019 (COVID-19) pandemic created a significant disruption in healthcare. In our health-system located in New York City, the provision of care in the ambulatory care setting moved to a remote model virtually overnight. We describe interventions made during the pandemic to transform ambulatory care pharmacy through expansion of telehealth services. Summary: In March of 2020, the closure of primary care clinics and provider appointment cancellations due to inpatient redeployment created a void. Collaboration with other health care providers and development of standardized telehealth workflows served as a conduit for creating new roles and opportunities for pharmacy team members. Three main interventions where the pharmacy team filled gaps include; (1) Expansion of pharmacist telemedicine visits for high-risk patients to improve access to primary care visits, (2) Partnership with nursing to create a centralized refill call center workflow, (3) Integration of pharmacy extenders into the prior authorization process to prevent medication access issues. Existing collaborative practice agreements for chronic disease management were utilized. A virtual pharmacist model for patient care contributed to an increase in telehealth visits from 51 in 2019 to 2997 total visits in 2020. In addition, the health-system refill call center expanded its services through collaboration with our pharmacy team. Pharmacists and pharmacy interns partnered with nurse practitioners to improve the call center workflow and address the significant increase in refill requests during the outbreak. Furthermore, a prior authorization process was created across multiple ambulatory care clinics to expedite medication access and prevent delays in therapy. Conclusion: Our ambulatory care pharmacy team leveraged technology, innovative workflows, and collaborative teamwork to catalyze a shift in pharmacists' and pharmacy extenders' roles in healthcare delivery to expeditiously meet patients' needs during a pandemic.

Mouse Navigation Strategies for Odor Source Localization.

Navigating an odor landscape is a critical behavior for the survival of many species, including mice. An ethologically relevant mouse behavior is locating food using information about odor concentration. To approximate this behavior, we used an open field odor-based spot-finding task indoors with little wind, examining navigation strategies as mice search for and approach an odor source. After mice were trained to navigate to odor sources paired with food reward, we observed behavioral changes consistent with localization 10-45 cm away from the source. These behaviors included orientation toward the source, decreased velocity, and increased exploration time. We also found that the amplitude of 'casting,' which we define as lateral back and forth movement of the nose, increased with proximity to the source. Based on these observations, we created a concentration-sensitive agent-based model to simulate mouse behavior. This model provided evidence for a binaral-sniffing strategy (inter-nostril comparison of concentration in a single sniff) and a serial-sniffing strategy (sampling concentration, moving in space, and then sampling again). Serial-sniffing may be accomplished at farther distances by moving the body and at closer distances by moving the head (casting). Together, these results elucidate components of behavioral strategies for odor-based navigation.

Opioid Medications Prescribing and the Pain-Depression Dyad in Primary Care: Analysis of 2014-2015 National Ambulatory Medical Care Survey (NAMCS) Data.

BACKGROUND: Increased drug overdose deaths have become a serious public health problem. Primary care providers prescribe about 50% all opioid medications. This study examined opioids prescribing during primary visits to patients with a pain-depression dyad and patient demographic characteristics associated with opioids prescribing. METHOD: This study analyzed data from the 2014 to 2015 National Ambulatory Medical Care Survey and included primary care visits by adult patients (aged 18 years or older) with noncancer pain. RESULTS: An opioid medication was prescribed in 26.4% (95% CI, 22.6% to 30.6%) of the primary care visits by patients with noncancer pain. Opioid medications were more likely to be prescribed during visits by patients with a pain and depression dyad (adjusted odds ratios [AOR] = 1.8; 95% CI, 1.4 to 2.4). Narcotic analgesics were more likely to be prescribed during visits by patients aged 46 to 64 years; by male patients or non-Hispanic white patients. DISCUSSION/CONCLUSIONS: Pain-depression dyad is associated with higher odds of opioids prescribing during primary care visits. Future studies are needed to understand the complexity of these factors and identify effective strategies to prevent opioids addiction and overdose among patients with pain and depression.

Serious Choices: A Systematic Environmental Scan of Decision Aids and Their Use for Seriously Ill People Near Death.

Seriously ill people near death face difficult decisions about life-sustaining treatments such as cardiopulmonary resuscitation and mechanical ventilation. Patient decision aids may improve alignment between patients' preferences and the care they receive, but the quantity, quality, and routine use of these tools are unknown. We conducted a systematic environmental scan to identify all decision aids for seriously ill people at high risk of death facing choices about life-sustaining treatments, assess their quality, and explore their use in clinical settings. We searched MEDLINE, Google, and mobile application stores and surveyed experts. We included 27 decision aids in our scan. Concerning content, 14 of 27 decision aids for seriously ill people near death were for people with specific diseases and conditions (ie, advanced cancer or kidney disease); 11 concerned individual life-sustaining treatment decisions (ie, cardiopulmonary resuscitation or mechanical ventilation). Only two focused on more general care pathways (ie, life-sustaining intervention, palliative care, and hospice). Twenty-four of 27 decision aids presented options in a balanced way; 23 identified funding sources, and 19 of 27 reported their publication date. Just 11 used plain language. A minority, 11 of 27, listed evidence sources, five documented rigorous evidence-synthesis methods, six disclosed competing interests, and three offered update policies. Preliminary results suggest that few health systems use decision aids in routine patient care. Although many decision aids exist for life-sustaining treatment decisions during serious illness, the tools are deficient in some key quality areas.

Risk Reduction to Disease Management: Clinical Pharmacists as Cardiovascular Care Providers.

Most cardiovascular diseases are caused by modifiable risk factors yet prevalence continues to increase and heart disease remains the leading cause of death in the United States. Screening, identifying and appropriately managing high risk patients are strategies to shift the paradigm from treatment to prevention. Pharmacists are an underutilized population health resource despite robust evidence to support their roles as interdisciplinary team members and direct patient care providers in both inpatient and outpatient settings. This article aims to highlight the multifaceted function and impact of clinical pharmacists on cardiovascular risk reduction and disease management.

Development and implementation of an interprofessional pharmacotherapy learning experience during an advanced pharmacy practice rotation in primary care.

BACKGROUND: There is increased focus and pressure to include interprofessional education during training of health professionals. This program describes an interprofessional education program between pharmacy, medical, and nurse practitioner students during a primary care clinical rotation elective. INTERPROFESSIONAL EDUCATION ACTIVITY: The interprofessional education program (IPE) during a primary care rotation was developed to be included as a learning experience throughout the rotation period. The health professions included have a role in appropriate prescribing; therefore, the content emphasis is primary care disease states where pharmacotherapy is a treatment modality. DISCUSSION: Data assessing the program was collected using the Interprofessional Education Perception Scale (IEPS) from April 2014 to April 2016. A total of 56 IEPS pre- and post-surveys were collected for analysis. A significant difference in the IEPS scale was found in the subgroups of (1) professional competence and autonomy and (2) perceived need for professional competence (p < .05). Qualitative results of the completed surveys show a trend of respectful and positive communication between students, lack of previous IPE experience prior to the intervention, and a collaborative environment where students had the opportunity to learn about each other's professions. Structured interactions between health professions student interactions during clinical rotations can be beneficial for students to learn about each other and may lead to better collaboration. The authors will use the current program as a foundation for other interprofessional activities between students.

A conserved Toll-like receptor-to-NF-κB signaling pathway in the endangered coral Orbicella faveolata.

Herein, we characterize the Toll-like receptor (TLR)-to-NF-κB innate immune pathway of Orbicella faveolata (Of), which is an ecologically important, disease-susceptible, reef-building coral. As compared to human TLRs, the intracellular TIR domain of Of-TLR is most similar to TLR4, and it can interact in vitro with the human TLR4 adapter MYD88. Treatment of O. faveolata tissue with lipopolysaccharide, a ligand for mammalian TLR4, resulted in gene expression changes consistent with NF-κB pathway mobilization. Biochemical and cell-based assays revealed that Of-NF-κB resembles the mammalian non-canonical NF-κB protein p100 in that C-terminal truncation results in translocation of Of-NF-κB to the nucleus and increases its DNA-binding and transcriptional activation activities. Moreover, human IκB kinase (IKK) and Of-IKK can both phosphorylate conserved residues in Of-NF-κB in vitro and induce C-terminal processing of Of-NF-κB in vivo. These results are the first characterization of TLR-to-NF-κB signaling proteins in an endangered coral, and suggest that these corals have conserved innate immune pathways.

Implementation of a Patient Navigator Program to Reduce 30-day Heart Failure Readmission Rate.

With increasing awareness to provide personalized care our institution applied the American College of Cardiology (ACC) Patient Navigator Program to identify hospitalized heart failure (HF) patients and improve transitions and outcomes. Utilizing a Navigator Team (NT) composed of a nurse and clinical pharmacist, we delivered evidenced-based interventions and hypothesized this approach would improve identification of HF inpatients and reduce the 30-day all-cause readmission rate. Patients were followed from admission to discharge and received at least one intervention, tailored to the patient's health literacy and social needs. The 30-day all-cause readmission rate was 17.6% for the Patient Navigator Program and 25.6% for the medical center. Compared to the medical center there was a statistically significant increase in education and follow-up. For patients who received specific NT interventions of education and follow-up the readmission rate was 10.3% and 6.1% respectively. Hospital programs can easily embed a NT into existing initiatives to further reduce the readmission rate.

Biosynthesis of Se nanoparticles and its effect on UV-induced DNA damage.

This paper reports, an environmentally benign procedure of synthesis and characterizations of selenium nanoparticles and their protective effect against UV-induced DNA damage activities. An aqueous leaf extract of lemon plant was used as a precursor for synthesis of colloidal selenium nanoparticles. Resulting nanoparticles were characterized using UV-vis spectrophotometer, photoluminescence, TEM, EDAX, FT-IR and XRD, respectively. Selenium colloidal solution exhibited an absorption maximum at 395 nm and produced an emission maximum at 525 nm. Transmission electron microscopy followed by selected area electron diffraction pattern analysis indicated the formation of spherical, polydispersed, crystalline, selenium nanoparticles of diameter ranging from (∼60 to 80 nm). X-ray diffraction studies showed the formation of 111, 200 and 220 planes of face-centered cubic (fcc) selenium. EDAX analysis confirmed the presence of selenium in nanosphere. Fourier transformed infrared spectroscopic investigation reveled the involvement of carboxyl (−C=O), hydroxyl (−OH), amine (−NH) functional group of lemon plant extract in preparation of selenium nanoparticles. MTT assay as well single cell gel electrophoresis assay or comet assay revealed that synthesized selenium nanoparticles, caused less cell death of lymphocytes and prevented DNA damage, when cells were exposed to UVB. The fluorescent property of selenium nanoparticles can be used as diagnostic agent. Further, their anti DNA damaging property can be investigated as a chemotherapeutic agent in cancer therapy.